Effect of Music During Carotid Endarterectomy
Effect of Music on Patient's Anxiety, Satisfaction and Pain During Carotid Endarterectomy: Multicenter Prospective Randomized Controlled Trial
1 other identifier
interventional
64
1 country
1
Brief Summary
The purpose of this study is to test the hypothesis that music listening during carotid endarterectomy administered the cervical plexus block will cause less anxiety, less pain, and greater patient satisfaction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2018
CompletedFirst Posted
Study publicly available on registry
March 7, 2018
CompletedStudy Start
First participant enrolled
March 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2018
CompletedJanuary 4, 2019
January 1, 2019
4 months
March 1, 2018
January 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Differences in intraoperative State-Trait Anxiety Inventory Response (relaxed )
Assessed every 5 minutes during the procedure. The question is "are you relaxed" and patient is asked to answer the question on a scale of "very much, moderately, somewhat, or not at all"
60 minutes
Secondary Outcomes (7)
Differences in intraoperative State-Trait Anxiety Inventory Response (calm)
60 minutes
Differences in postoperative anxiety numerical rating scale scores
10 minutes
Differences in preoperative State-Trait Anxiety Inventory scores
20 minutes
Differences in postoperative State-Trait Anxiety Inventory scores
20 minutes
Differences in pain scores
10 minutes
- +2 more secondary outcomes
Study Arms (2)
music group
ACTIVE COMPARATORin music group, patient was asked to choose one music genres from 5 different music genres according to his/her preference. Patient selected music was delivered by an iPhone 6 and Music app (Apple Inc., USA) through the iPhone's headphones.
operating room noise group
ACTIVE COMPARATORin operating room noise group, operating room noise was delivered by an iPhone and Microphone App (Free version, Von Bruno). This application allows the iPhone to be used as a live microphone.
Interventions
Eligibility Criteria
You may qualify if:
- Patients undergoing carotid endarterectomy using cervical plexus block
- American Society of Anesthesiologists class 2 to 3
- Ability to consent
You may not qualify if:
- inability to communicate
- not understand the aim and objectives of the study
- not provide informed written consent
- contraindications for the block (local infection, coagulation disorders)
- hypersensitivity to the local anesthetics
- refusal of regional anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Antalya Training and Research hospital
Antalya, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ali Sait Kavakli, M.D.
Antalya Training and Research Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2018
First Posted
March 7, 2018
Study Start
March 15, 2018
Primary Completion
July 15, 2018
Study Completion
September 15, 2018
Last Updated
January 4, 2019
Record last verified: 2019-01